Pilling Wecksorb Cylindrical Sponges recalled due to compromised sterility
TELEFLEX LLC recalled 1,000 units of Pilling Wecksorb Cylindrical Sponges (Lot 22B0395) because certain lots were not irradiated to eliminate pyronema, potentially compromising sterility. No illnesses have been reported.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall with no reported hospitalizations or injuries. The hazard—compromised sterility due to inadequate irradiation—represents a risk-of-harm product where injury has not yet been reported, which per the severity rubric classifies as High.
Plain-English summary
TELEFLEX LLC is recalling 1,000 units of Pilling Wecksorb Cylindrical Sponges due to a sterilization defect. Catalog Number 200400, Lot Number 22B0395 were not irradiated to eliminate pyronema, which may compromise the sterility of the affected products.
The affected sponges were distributed domestically to Illinois, Mississippi, Pennsylvania, and Tennessee. Customers who have received the affected product should contact TELEFLEX LLC or their healthcare provider for instructions on how to proceed. Healthcare facilities should review their inventory for the affected lot number and take appropriate action to prevent use of potentially non-sterile products.
The recalled product
- Product
- Pilling Wecksorb Cylindrical Sponges
- Manufacturer
- TELEFLEX LLC
- Affected units
- 1,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Catalog Number: 200400
- Lot Number: 22B0395
Distribution
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